SGLT2 inhibitors: initiation of a European safety review to evaluate the risk of diabetic ketoacidosis
2015.06.16
Active substance: canagliflozin | dapagliflozin | empagliflozin
The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.
To the risk assessment procedure (available in German only)
Details on the procedure can be found on the website of the European Medicines Agency (EMA):